AVEO Pharmaceuticals
Senior Director, Pharmacovigilance Operations
AVEO Pharmaceuticals, Boston, Massachusetts, us, 02298
JOB TITLE:
Senior Director, PV Operations DEPARTMENT:
Pharmacovigilance REPORTS TO:
VP Pharmacovigilance LOCATION:
Boston or Hybrid DATE PREPARED:
December 16, 2024
JOB SUMMARY: The Senior Director Pharmacovigilance (PV) Operations will be accountable for the overall PV operations, which includes all aspects of adverse event collection, processing and reporting from all sources, vendor management, and associated PV quality management, for entire portfolio in clinical development and post approval. The Senior Director PV operations leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance. The position below will be based in Boston or hybrid, with regular travel to Boston office based on business needs.
PRINCIPAL DUTIES: Develops and implements the strategy for PV system, processes, and vendor deployment. Responsible for all PV operational aspects for entire portfolio in clinical development and post approval. Oversees the system for ICSR collection, processing, reconciliation, and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met. Facilitates and ensures communication with internal functions and external vendors and license partners involved with receiving, investigating, or reporting AEs. Provides oversight on PV vendors performing safety services. Supports the development and maintenance of PV agreement with license partners and/or other parties. Supports PV procedure development and maintenance that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle. Supports PV audit, inspection, and CAPA activities as required. Supports signal detection, aggregate report preparation and safety labeling updates. Supports the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/MAA, and other regulatory submissions. Supports business development activities including due diligence when required. Ensures awareness and training of appropriate Company personnel and external groups of PV principles, policies, and SOP. Provides PV guidance and support for interdepartmental and/or corporate initiatives. Leads and develops PV operations team. Participates in the development and management of departmental budget.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience highly desirable. Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry is required, including 5 years in management position with direct reports on the sponsor side overseeing business process outsourcing vendors and relationships. Experience with marketed and development stage oncology products is preferred. Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines. Experience and extensive working knowledge of MedDRA and proprietary safety databases. Experience and extensive working knowledge of PV processes for individual case handling, signal detection and evaluation, aggregate data assembly, review, and report, as well as clinical study safety management. Extensive experience with audit and inspection. Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels. Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization. Proficient with Microsoft Office. Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to details.
About AVEO: AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Senior Director, PV Operations DEPARTMENT:
Pharmacovigilance REPORTS TO:
VP Pharmacovigilance LOCATION:
Boston or Hybrid DATE PREPARED:
December 16, 2024
JOB SUMMARY: The Senior Director Pharmacovigilance (PV) Operations will be accountable for the overall PV operations, which includes all aspects of adverse event collection, processing and reporting from all sources, vendor management, and associated PV quality management, for entire portfolio in clinical development and post approval. The Senior Director PV operations leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance. The position below will be based in Boston or hybrid, with regular travel to Boston office based on business needs.
PRINCIPAL DUTIES: Develops and implements the strategy for PV system, processes, and vendor deployment. Responsible for all PV operational aspects for entire portfolio in clinical development and post approval. Oversees the system for ICSR collection, processing, reconciliation, and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met. Facilitates and ensures communication with internal functions and external vendors and license partners involved with receiving, investigating, or reporting AEs. Provides oversight on PV vendors performing safety services. Supports the development and maintenance of PV agreement with license partners and/or other parties. Supports PV procedure development and maintenance that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle. Supports PV audit, inspection, and CAPA activities as required. Supports signal detection, aggregate report preparation and safety labeling updates. Supports the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/MAA, and other regulatory submissions. Supports business development activities including due diligence when required. Ensures awareness and training of appropriate Company personnel and external groups of PV principles, policies, and SOP. Provides PV guidance and support for interdepartmental and/or corporate initiatives. Leads and develops PV operations team. Participates in the development and management of departmental budget.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience highly desirable. Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry is required, including 5 years in management position with direct reports on the sponsor side overseeing business process outsourcing vendors and relationships. Experience with marketed and development stage oncology products is preferred. Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines. Experience and extensive working knowledge of MedDRA and proprietary safety databases. Experience and extensive working knowledge of PV processes for individual case handling, signal detection and evaluation, aggregate data assembly, review, and report, as well as clinical study safety management. Extensive experience with audit and inspection. Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels. Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization. Proficient with Microsoft Office. Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to details.
About AVEO: AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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